Expanding Access to Cognitive Health Biomarker Testing at Home

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07594665
Status
Enrolling By Invitation

Conditions

  • Alzheimer's Dementia (AD)
  • Cognitive Aging
  • Mild Cognitive Impairment (MCI)
  • Subjective Cognitive Decline (SCD)

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The goal of this observational study is to learn whether at-home blood biomarker testing for Alzheimer's disease risk is feasible and acceptable in older adults with cognitive concerns. The main questions it aims to answer are: * Can older adults with subjective cognitive concerns or possible mild cognitive impairment successfully complete a fully remote workflow that includes at-home capillary blood collection, overnight shipping, central laboratory analysis of phosphorylated tau-217 (p-tau217), and remote disclosure of results by a neurologist? * Is this remote at-home p-tau217 testing workflow acceptable to participants? Participants are adults aged 65 and older who participated in the SHUTi MIND parent study (NCT05565833) and report subjective cognitive concerns or screen positive for possible mild cognitive impairment. Participants will collect a small capillary blood sample at home, return the sample to a central laboratory by overnight shipping for p-tau217 analysis, receive their result during a remote visit with a board-certified neurologist, and complete online surveys at baseline, after results disclosure, and 6 months post-disclosure.

Key Dates

Start date
May 18, 2026
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Older Adults with Cognitive Concerns
    Adults aged 65 years and older who are participants in the SHUTi MIND parent study (IRB-HSR #220077), reside in the United States, and report subjective cognitive concerns or screen positive for possible mild cognitive impairment based on the Telephone Interview for Cognitive Status (TICS). Participants undergo at-home capillary blood collection for plasma p-tau217 testing, remote results disclosure by a board-certified neurologist, and longitudinal online surveys.

Primary Outcome Measure

Acceptability of remote, at-home p-tau217 workflow [ Time Frame: From enrollment through study completion (~7 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Virginia, School of NursingCharlottesvilleVirginia22908-

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By research site
University of Virginia, School of Nursing· Charlottesville, VA

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